Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer's lactate 2500 cc IV | Experimental |
| |
| Ringer's lactate 2000 cc IV | Experimental |
| |
| Ringer's lactate 1500 cc IV | Experimental |
| |
| Ringer's lactate 1000 cc IV | Experimental |
| |
| Ringer's lactate 500 cc IV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ringer's lactate | Other | Intravenous Ringer's lactate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum amylase | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatitis | Abdominal pain characteristic of pancreatitis occurring after ERCP resulting in admission of (or prolongation of admission by) at least 2 nights, with one or more of: (1) amylase and/or lipase > 3 times the upper limit of normal when measured at least the day after ERCP and/or (2) imaging findings characteristic of pancreatitis. | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nauzer Forbes, MD, MSc | Contact | 403-880-8508 | nauzer.forbes@ucalgary.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Centre | Recruiting | Calgary | Alberta | T1Y 6J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42203288 | Derived | Forbes N, Guo H, Kruk A, Ficaccio S, Cartwright S, Howarth M, Malik G, Nietert PJ, Smith ZL, Li S, Chen YI, Causada Calo N, Tse F, Telford JJ, Cook DJ, Hill MD, Elmunzer BJ. Short-term intravenous fluids for prevention of post-ERCP pancreatitis (the STRIPE study): protocol for a five-arm randomised controlled trial. BMJ Open. 2026 May 27;16(5):e119154. doi: 10.1136/bmjopen-2026-119154. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bleeding | Hematemesis, melena, or hematochezia (other than blood on toilet paper) resulting in one or more of the following: (1) hemoglobin drop > 2g and/or a need for transfusion, (2) a procedure performed for evaluation of suspected bleeding, and/or (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night. | 30 days |
| Cholangitis | Presentation that includes all of the following: (1) temperature < 36.0°C or > 38.0°C or white blood cell count < 4,000/L or > 10,000/L and (2) increase in bilirubin, alkaline phosphatase, or transaminases compared to pre-procedure, or, if previously normal, a rise in any parameter to > 1.5 times the upper limit of normal, and (3) emergency department visit and/or admission to hospital and/or prolongation of existing admission by at least one night. | 14 days |
| Cardiorespiratory adverse event | Cardiorespiratory signs and/or symptoms related to a non-gastrointestinal organ system, or sedation- or drug-related reaction occurring during or after ERCP. The event must (1) result in an unplanned emergency department visit, hospital admission, or prolongation of existing admission by at least one night and/or (2) prevent completion of the planned procedure and/or (3) result in death. | 7 days |
| Serum lipase | 24 hours |
| Electrolytes | 24 hours |
| Creatinine | 24 hours |
| Brain natriuretic peptide | 24 hours |